36E79720R0014-001.docx

36E79720R0014

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36E79720R0014 03-31-2020 Ray Roldan raymond.roldan@va.gov 708-786-4930 04-14-2020

10:59 PM CT

Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141 X Y 339113 750 Employees N/A N/A X VA Pharmaceutical Prime Vendor Refer to Attachment A, located in Section D.

Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141

VA Pharmaceutical Prime Vendor Refer to Attachment A, located in Section D.

See CONTINUATION Page Compression Bandage System and Gauze Sponges Award will be made in the aggregate for Group I, line items 1 and 2; and Group II, line items 1, 2, 3, 4, and 5.

The Government may award two separate contracts for Group I and Group II, or one contract for both groups.

To be considered for award, offerors must submit a price for the base year and all four options years for the Group proposed.

Prices offered shall not exceed two decimal places.

Offered prices must include the Cost Recovery Fee of 0.5%, as outlined in Scope of Contract. Offerors must list a 12-digit GTIN or UPC number for offered item that is unique to the offeror or manufacturer as outlined in the scope of contract.

See CONTINUATION Page X X 1 scan 19.

Item No.

20.

Schedule of Supplies/Services

21. Quantity 22.

Unit 23.

Unit Price 24.

Amount

Group 1 (line items 1, and 2), and Group 2 (line items 1, 2, 3, 4, and 5) represent two separate requirements for purposes of FAR Clause 52.217-9, “Option to Extend the Terms of the Contract” and Clause 52.233-2 “Service of Protest”. For the purpose of determining the lowest-priced, technically acceptable offer(s) the Government will evaluate each group separately. To be considered for award, offeror(s) shall submit a price for all line items within each product group on which an offer is made for the base and all four option years. Alternate offers will be considered for a combination of product groups. If, after evaluation, a proposal offering multiple groups results in the lowest-priced, technically acceptable proposal, the Government may award the multiple product groups under a single contract. See 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014).

Award will be made in the aggregate for Group I, line items 1 and 2; and Group II, line items 1, 2, 3, 4, and 5. The Government may award two separate contracts for Group I and Group II, or one contract for both groups. Offered prices shall not exceed two decimal places.

GROUP I

GTIN#: __________________

UPC #: _________________

GTIN #: __________________

UPC #: _________________

Product Samples. Offerors shall provide one sample (one kit) for each line item proposed, that is an identical version of the compression bandage kit that would be used to fulfill the requirements of this solicitation. As the items from group one will be ordered individually, the samples must include the GTIN/UPC and must be sterile, as indicated in the product requirements. Samples will be used to evaluate compliance with the salient characteristics listed for each line item above and in Attachment “B” and will not be returned. The samples must be submitted by the due date for offers. Any offer whose proposed samples fail to meet the minimum requirements shall be rejected and shall receive no further consideration.

GROUP II

Sponge, Woven Gauze: 100% cotton, USP Type VII woven gauze sponge. Size 4” x 4”, 8-ply, non-sterile. Not made with natural rubber latex. 200/pack.

GTIN#: __________________

UPC #: _________________

UPC #: _________________

UPC #: _________________

GTIN #: ________________

UPC #: ________________

GTIN #: _______________

UPC #: _________________

Product Samples. Offerors shall provide one sample (i.e. 1 pack of sponge gauze) for each line item proposed, that is an identical version of the sponges that would be used to fulfill the requirements of this solicitation. Samples will be used to evaluate compliance with the salient characteristics listed for each line item above and in Attachment B and will not be returned. Note that because the samples will not be provided in the same case/quantity as those for the contract, it is understandable that the samples may not contain the GTIN/UPC, but must be sterile, if applicable, per line item. The samples must be submitted by the due date for offers. Any offer whose proposed samples fail to meet the minimum requirements shall be rejected and shall receive no further consideration.

Please indicate the FDA 510K Approval Number or Numbers for the offered products below:

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES

Please be advised the following are included in the solicitation and are highlighted here.

Proposals may be delivered to Department of Veterans Affairs, National Acquisition Center, National Contract Service (003B6C3), 1st Avenue, 1 Block North of Cermak Road, Building 37, Hines, IL 60141. Proposals will also be accepted in Microsoft Word or PDF form via e-mail at raymond.roldan@va.gov with a scanned (pdf) copy of the signed SF1449. Offerors are not required to submit an original proposal if an electronic proposal was received. Please note that faxed proposals are not acceptable and will be rejected. Reference FAR 52.212-1(f) regarding timeliness of submission of offers.

If the offeror is not the manufacturer of the offered items, the offeror shall submit a letter of commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period. “Manufacturer” is defined as the entity that produces the product. This requirement shall be met before contract award. Offers that fail to submit a letter of commitment before contract award shall be rejected and shall receive no further consideration. (See Addendum 52.212-1 – Instruction to Offerors).

Award will be made in the aggregate to the responsible contractor(s) per individual product group or for both product groups if this results in the lowest overall price for the Government. To be considered for award, offerors must propose prices for the base and each option year for all the items within a product group or groups proposed:

Group I – lines items 1 and 2 Group II – lines items 1, 2, 3, 4, and 5

(Refer to Schedule of Supplies for package size details and estimates)

Offered prices shall include a 0.50% Cost Recovery Fee (Scope of Contract, paragraph 9).

The Government will evaluate offers in accordance with the policies and procedures of the Federal Acquisition Regulation (FAR) Part 25.

Acknowledgement of Amendments. The following amendments are acknowledged as part of this solicitation. (Please complete if applicable)

The System for Award Management (SAM) is an online system that replaces CCR/FedReg, ORCA, and EPLS. Contractors should now go to www.sam.gov to find their information. Training tools are available on the SAM website at www.sam.gov for familiarization with the SAM system. Prospective contractors shall maintain a current and accurate record in the SAM database. SAM updates are required, as necessary, but at least annually.

Subcontracting Plan Requirements: Pursuant to the requirements of 15U.S.C.644, all large business concerns are required to have an approved subcontracting plan for contracts valued over $700,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval. Attachment “C” includes all of the elements required to be addressed and is included to facilitate the submission of a subcontracting plan. Note: The dollar value of $150,000 provided in paragraph (d)(11)(iii) of 52.219-9 which is incorporated by reference at 52.212-5(b)(17)(iii)] is revised to $250,000 in accordance with VA Class Deviation dated March 22, 2018.

As prescribed in FAR Part 42.15, VA evaluates contractor performance on all contracts that exceed the Simplified Acquisition Threshold, which was raised to $250,000, by a VA Class Deviation dated March 22, 2018, and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, VA will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at http://www.cpars.gov and uploaded to PPIRS (Past Performance Information Retrieval System).

SCOPE OF CONTRACT

1. INTRODUCTION

1.1 Background. All Ordering Activities under the VA acquire their requirements through the Pharmaceutical Prime Vendor Program (PPV). The PPV Program is a separate contract which establish the fees for the distribution of pharmaceutical and some medical surgical products that are distributed through the PPV Program on Federal Government (i.e., Federal Supply Schedules, National Standardization) contracts. A contract resulting from this solicitation establishes the VA National Contract prices for the products listed in the schedule of supplies that will be distributed through the PPV Program. Section 2.1, “Government Participants” lists the PPV Program participants that will be authorized users of the contract resulting from this solicitation.

1.2 Purpose and Objectives. The purpose of this solicitation is to establish a supply source that will provide the products listed in the schedule for purchase through the PPV Program for outpatient pharmacy dispensing at the medical facility level for VA, Indian Health Services (IHS), Bureau of Prisons (BOP) and Federal Health Care Center (FHCC). The total annual estimated usage for outpatient pharmacies for the above agencies appears on the Schedule of Supplies section of this Solicitation. The total annual estimated usage for VA Pharmacies appears on the Schedule of Supplies section of this Solicitation. The objective of such a contract is to ensure availability and consistency of product for nationwide usage and to obtain volume-based, committed use pricing.

1.3 Government Purchase Compliance. Medical Facility Outpatient Pharmacy Personnel will purchase their requirements for the medical items listed in the schedule through the PPV Program except when: (1) the contracted items are unavailable to meet the needs of the Government, (2) an alternate is requested by the prescribing healthcare provider, or (3) additionally, IHS may not participate if the awardee does not have a Centers of Medicare or Medicaid (CMS) reimbursable product(s). If 1, 2, or 3 applies, these instances will be considered exceptions to section C.3 – 52.216-21, Requirements. VA’s PPV contract has ordering lock-out procedures in place to support VA contract compliance and to prevent purchases of non-contract products. For the purposes of any contract resulting from the solicitation, participants of the VA PPV Program include the outpatient pharmacies dispensing at the medical facility level for VA, IHS, BOP and FHCC.

1.4 Contract Effective Date. The contract will be effective on the date the Contracting Officer signs the SF1449 and notifies the contractor of award. The first 60 days of the contract period (or a shorter time period, if mutually agreed between the contractor and Government) will be an implementation period when the PPVs begin placing orders with the contractor for delivery to multiple PPV distribution centers. Orders placed with the PPV by Government participants will begin shipping under this contract upon the expiration of the 60-day implementation period. There are approximately 31 VA PPV Distribution Centers located nationwide. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available, and that chargeback agreements with the PPV have been executed with sufficient time to permit the PPV to begin timely distribution of Government orders by the expiration of the contract implementation period. The current PPV is listed as attachment “A” of this solicitation. The current PPV may change and the contractor will be notified of any changes to the PPV contractor during the term of the contract resulting from this solicitation. Payment terms, time and place of delivery to PPV distribution centers and other business-to-business agreement terms shall be agreed upon between the PPV contractor and the contractor awarded a contract from this solicitation. The Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPVs by 15 days before commencement of the period of performance. Failure or refusal to reach agreement with the PPV shall constitute sufficient cause for terminating the contract under Federal Acquisition Regulation Part 52.212-4(m), Contract Terms and Conditions-Commercial Items, Termination for Cause.

1.5 Contract Duration. The contract(s) resulting hereunder will be in effect for one (1) year with four (4) one-year pre-priced option periods that may be exercised unilaterally by the Government in accordance with FAR 17.207 and FAR 52.217-9.

1.6 Special Contract Considerations. As discussed in Section 1.2, this solicitation establishes a supply source to provide the products listed in the schedule for purchase through the PPV program. Additionally, as outlined in Section 1.4, the awarded contractor under this solicitation must reach a business-to-business agreement with the PPV. Because the PPV distributes the supplies sourced from this solicitation, special contract considerations apply. Under this resulting contract, the contractor will be receiving payments from the PPV instead of directly from the Government. Due to this unique payment structure, contractors are not permitted to assign their rights to receive payment under this contract. Additionally, disputes arising between a Contractor and any authorized Government Prime Vendor does not give rise to a “claim” under the Disputes Clause. Finally, no invoices will be provided from the Contractor to the Government ordering facilities. Instead, the contractor shall submit invoices in accordance with the business-to-business agreements reached with the PPV.

2. EXTENT OF OBLIGATION

2.1 Government Participants. The contractor shall provide the products specified in the schedule at the prices awarded herein for all outpatient pharmacies dispensing at the medical facility level for VA, IHS, BOP and FHCC.

2.2 Product Samples. Offerors shall provide one sample for Group I, line items 1 and 2, and Groups II, line items 1, 2, 3, 4, and 5, of the compression bandage kits and sponge gauzes that would be used to fulfill the requirements of this solicitation.

Group I: Offerors shall provide one sample (one kit) for each line item proposed, that is an identical version of the compression bandage kit that would be used to fulfill the requirements of this solicitation. As the items from group one will be ordered individually, the samples must include the GTIN/UPC and must be sterile, as indicated in the product requirements. Samples will be used to evaluate compliance with the salient characteristics listed for each line item above and in Attachment “B” and will not be returned. The samples must be submitted by the due date for offers. Any offer whose proposed samples fail to meet the minimum requirements shall be rejected and shall receive no further consideration.

Group II: Offerors shall provide one sample (sponge gauze) for each line item proposed, that is an identical version of the sponges that would be used to fulfill the requirements of this solicitation. As the items from group one will be ordered individually, the samples must include the GTIN/UPC and must be sterile, as indicated in the product requirements. Samples will be used to evaluate compliance with the salient characteristics listed for each line item above and in Attachment B and will not be returned. Samples will be used to evaluate compliance with the salient characteristics listed for each line item above and in Attachment “B” and will not be returned. Note that because the samples will not be provided in the same case/quantity as those for the contract, it is understandable that the samples may not contain the GTIN/UPC. The samples must be submitted by the due date for offers. Any offer whose proposed samples fail to meet the minimum requirements shall be rejected and shall receive no further consideration.

The samples must be submitted by the due date for offers. Any offer whose proposed samples fail to meet the minimum requirements shall be rejected and shall receive no further consideration.

2.3 Estimated Quantities.

The quantities in the schedule reflect the usage of all outpatient pharmacies dispensing at the medical facility level for VA, IHS, BOP and FHCC.

These estimated annual requirements do not include those of any other Government agency, including those currently participating in the VA PPV Program (e.g. Indian Health Service, Bureau of Prisons, Immigration and Customs Enforcement, Option 1 & 2 State Veteran’s Homes). The estimated usage cited in the Schedule is the Government’s total estimated usage for the sizes listed. There is no expressed or implied guarantee that the estimated quantity will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented.

3. NATIONAL CONTRACT ITEM BACKORDERS

A contract awarded under this solicitation will be the primary source of supply for outpatient pharmacies dispensing at the medical facility level for VA, IHS, BOP, and FHCC (See FAR 52.216-21 Requirements). The Government’s ability to provide quality healthcare to its patient population is severely impaired when a national contract product is not available due to backorders. The purpose of this paragraph is to provide guidance to the awarded contractor regarding a temporary solution to national contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, consideration of this paragraph shall not waive any of the Government’s rights to terminate the contract for cause in accordance with FAR 52.212-4(m).

For purposes of this contract, a backorder occurs when the PPV issues an order with the contractor awarded a contract for the products in this solicitation, and the complete order quantity is not delivered to the PPVs within 15 days after receipt of order. If a national contract item is backordered by the PPVs, the VA National Acquisition Center (VANAC) contracting officer will investigate the backorder to determine if the national contract contractor bears responsibility for the backorder. The awarded contractor shall inform the VANAC contracting officer within 4 calendar days after a backorder occurs. In addition to informing the contracting officer of the backorder, the contractor shall provide an estimated date when the backorder will be shipped and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the contractor may propose to alleviate a national contract backorder situation. If the contracting officer determines that the contractor bears responsibility for the backorder, and the contractor is not able to provide a solution that is acceptable to the Government, (i.e., acceptable solution to the backorder, in lieu of Termination for Cause), the parties agree that the Government may buy against the contractor by acquiring the same or similar items from another source and billing the contractor for any excess procurement costs. In other words, if the government must purchase product from another vendor because of a national contract backorder, the contractor will issue credit or reimburse the Government for the difference between the purchase price and the contract price within 30 calendar days after receipt of notification. The contractor shall also provide written verification to the Contracting Officer when credits or reimbursement have been made within 30 calendar days from date of reimbursement. After a backorder incident occurs for which the Contractor is responsible, the Government’s decision to enter into a buy-against agreement described above will not deprive the Government of its right under Clause 52.212-4 (m) to terminate the contract for a breach of the buy-against agreement, for a subsequent contractor-caused backorder, or for any other sufficient cause.

4. PACKAGING REQUIREMENTS

Offerors must state the exact name of the product being supplied as it will appear on the label. Offerors shall also provide a unique 12-digit GTIN or UPC number for all items offered; the GTIN number must be specific to the offering company or the manufacturer for the item being supplied. Items are identified in the Schedule of Supplies and in Attachment “B”.

5. BAR CODING

All products provided under this contract shall include bar code labeling compliant with commercial standards and compliant with any requirements of the PPV. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements.

The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 DataBar (formerly RSS), or Universal Product Code

The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this paragraph prior to shipping products to any Government Prime Vendor under this contract.

The bar code must be on the outside container or wrapper of the product as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap must contain the bar code.

When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging. A human readable number must be placed adjacent (preferably below) the encoded bar code to ensure product is usable with VA Bar Code medication Administration (BCMA) in the event the bar code is in some way damaged.

It is recommended that bar code labeling also include the lot number and expiration date.

6. GLOBAL TRADE ITEM NUMBER / UNIVERSAL PRODUCT CODES

Offerors shall provide a unique 12-digit GTIN or UPC number for all items offered; the GTIN number must be specific to the offering company or the manufacturer for the item being supplied for each product proposed, in the space provided following each item in block 20 of the SF1449, “Schedule of Supplies and Prices” of the solicitation. Offers that fail to provide the information required by this paragraph by the solicitation closing date may be rejected and receive no further consideration.

7. FDA APPROVAL

All offerors shall indicate their FDA 510K approval number or numbers for the offered products in the Schedule of Supplies. The Government will use this number to verify that the FDA 510K approval is present on the FDA’s database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm). If an offeror’s approval is not present on the FDA’s website (e.g. a new approval), the FDA approval letter shall be provided along with the offer. If the offered products are exempt from FDA 510K approval, the offeror shall indicate as such and shall provide evidence of the applicable exemption at the time of offer submission.

8. RECALLS

If a product recall is initiated for any product provided under this contract, regardless of whether it is a voluntary recall by the manufacturer, or a recall required by the U.S. Food and Drug Administration (FDA); the contractor shall immediately forward two copies of the recall notification along with any pertinent information to:

Chief, Pharmaceutical Division (003B6C3) VA National Acquisition Center National Contract Service 1st Ave., 1 Block North of Cermak Rd., Bldg. 37 P.O. Box 76, Hines, IL 60141 Fax Number (708) 786-5256

Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax Number (708) 786-7894

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865

All Government Prime Vendors that were sent shipments of the affected product(s).

9. COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS

(a) Quarterly Sales Reports. The Contractor shall report all contract sales under this contract and submit collected Cost Recovery Fees as follows:

(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). A Cost Recovery Fee equivalent to 0.5 % of the current contract price shall be collected from all contract users. The 0.5 % Cost Recovery Fee shall be imbedded in the awarded contract prices and offers submitted in response to this solicitation shall include the Cost Recovery Fee in every line item price offered. The reported contract sales shall include the cost recovery fee and each quarterly report shall show the total cost recovery fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice.

(2) Contract sales reports are due to the VA contracting officer within 60 calendar days following the completion of each reporting quarter or completion of the contract, whichever occurs first. A report is required even when no billings or invoices are issued, or no orders are received during the contract period.

(3) The sales report signed by an authorized representative of the contractor shall be sent by mail to the address listed below, to the Contracting Officer’s email, or facsimile to the contracting officer. Facsimile transmissions may be made to: (708) 786-5256.

Department of Veterans Affairs National Acquisition Center (003B6C3) P.O. Box 76 First Avenue, 1 Block North of Cermak, Bldg. 37 Hines, IL 60141

(4) In addition to the submission of quarterly sales reports due to the contracting officer within 60 days after the end of each reporting quarter, contractors shall provide copies of sales reports simultaneously with contractor’s cost recovery fee payment submissions via facsimile, to the attention of C.R. Agent Cashier, fax: (708) 786-7525 or email: AMMHINBOCFISCAL@VA.GOV

(b) Cost Recovery Fee. The 0.5 % Cost Recovery Fee amount collected and due shall be paid either electronically or by check and shall be addressed to the “Department of Veterans Affairs”. When the Contractor has multiple national contracts, the fee may be consolidated into one check. Consolidated payments for multiple contracts shall identify each contract number included, dollar amount remitted for each contract number, and reporting quarter.

To ensure that the payment is credited properly, the contractor shall identify the check or electronic transmission as a “Cost Recovery Fee” and include a copy of the applicable Sales Report. The Cost Recovery Fee payment is due to the Fiscal Division at the same time the sales report is due to the contracting officer, i.e., within 60 calendar days following the completion of each reporting quarter or completion of the contract.

Cost Recovery Fee payments shall not be combined with any Industrial Fund Fee payments. Contractors shall remit separately any Industrial Fund Fee payments in support of any of the Contractor’s Federal Supply Schedule contracts.

Cost recovery fee payments made electronically shall include the following information:

Contract Number(s): (Contractor shall insert the contract number, which will be assigned by the VA contracting officer at time of award.)

Cost recovery fee payments made in check form shall be made to the attention of “Department of Veterans Affairs” and mailed to the following address:

(c) The Government reserves the right to inspect without further notice, such records of the Contractor as pertain to sales under any contract resulting from this solicitation. Willful failure or refusal to furnish the required reports, or falsification thereof, shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions - Commercial Items, Termination for Cause.

(d) Failure to remit the full amount of the Cost Recovery Fee within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of (FAR) 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the Cost Recovery Fee, the Government shall have, in addition to the rights and remedies described in this paragraph, all other rights and remedies permitted by Federal law and statutes.

10. MANUFACTURING FACILITIES/PLACE OF PERFORMANCE

1. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility.

2. Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered. “Manufacturer” is defined as the entity that designs, manufactures, packages, and labels the product before it is available for sale/distribution.

3. The offeror is required to indicate below the complete name and address(es) of the manufacturer. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

( ) OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS OFFERED ON THIS SOLICITATION.

( ) OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION.

The offeror must maintain the same manufacturer for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. This determination may take place before or after contract award.

THE PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING LOCATIONS:

(Name of Manufacturing Company)

(Street Address of Manufacturing Facility) (Post Office Address Not Acceptable)

(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment. —

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience.